Gastric port system

ABSTRACT

A gastric port system for transport of materials to the interior of a body cavity that may include a port configured to be disposed between a first body cavity and an area adjacent to the first body cavity. The gastric port system may further include a first bolster disposed on the port where the first bolster includes a magnet, and a second bolster disposed on the port where the second bolster includes a magnet, and the magnets are attracted to each other.

BACKGROUND

The present system relates to medical devices, and more particularly, togastric port systems for delivery of materials to the interior of a bodycavity.

Patients for which normal ingestion of food becomes difficult orimpossible may require placement of a feeding tube to assist inproviding their nutritional needs. For some individuals, such ascomatose patients, stroke victims, or those with a compromisedgastrointestinal tract and the like, this may require placement of atube that is introduced percutaneously into the stomach for delivery ofnutritional products directly into the stomach or jejunum. Theprocedure, known as a Percutaneous Endoscopic Gastrostomy (PEG),involves the introduction of an endoscope into the stomach. The desiredsite where the stoma is to be created is indicated from above bydepressing the abdomen and viewing the depressed site with theendoscope. Transillumination may also be utilized to locate the desiredsite through the abdominal wall. A sheathed needle or trocar puncturesthe abdominal wall and enters the stomach, creating a stoma. The needleis removed and a looped insertion wire is introduced through the sheathwhere it is grasped by a snare or forceps deployed from the workingchannel of the endoscope. Once it is captured, the insertion wire ispulled into the working channel of the endoscope. The endoscope is thenwithdrawn from the patient via the oral cavity, pulling the insertionwire with it.

In the standard Ponsky method (or “pull” method), the distal loop of apercutaneous gastrostomy feeding tube is coupled to the insertion wireloop exiting the patient's mouth. With the insertion wire now tetheredto the gastrostomy feeding tube, the endoscopist retracts the portion ofthe insertion wire exiting the stoma, thereby pulling the gastrostomyfeeding tube into the patient's mouth and towards the stomach. Withcontinued retraction of the insertion wire, the distal end of thegastrostomy feeding tube is pulled out through the stoma. Thegastrostomy feeding tube typically includes a tapered dilator portion toaid its passage through the stoma. Once the feeding tube has beenproperly positioned with the proximal end cap or bolster of the feedingtube against the internal wall of the stomach, it is secured by anexternal bolster positioned against the outside of the abdomen wall.

In a variation of the PEG procedure known as the “push” method, thegastrostomy feeding tube is advanced or pushed down the esophagus by thephysician and into position in the stomach using a wire guide that hasbeen placed in the same manner as the insertion wire in the “pull”method. More specifically, the feeding tube is loaded on the portion ofthe wire guide exiting the patient's mouth by passing the end of thewire guide through a lumen extending through the length of the feedingtube. While holding the wire guide stationary, the physician pushes thefeeding tube along the wire guide through the patient's mouth, into thestomach, and then out through the stoma. The feeding tube is thensecured in the same manner as the “pull” method.

Yet another method is simply to insert the feeding tube through thepatient's abdominal wall and bypass insertion through the mouth.However, this method typically requires the attachment of a bolster tothe interior portion of the feeding tube, which may need to be deliveredand attached endoscopically. Alternatively, when the device has a lowprofile, it may be inserted using the Seldinger technique.

As stated above, typically, a retention bolster is positioned againstthe inside and/or outside of the abdomen wall, or whichever body cavityor area the gastric port is being used in relation to. The bolster ispresent to keep in place and support the gastric port and prevent suddenor unexpected removal of the port from the stoma site. Bolsters forsupporting ports, such as feeding tubes, inside or outside the body havegenerally focused on maintaining the secure anchoring of the device tothe patient. To provide support, bolsters have employed flanges,cross-bars, discs, or balloons for contacting the surface of the tissue.In the past, however, bolsters have tended to increase the localizedpressure at the exit site, especially when the port, either accidentallyor intentionally, is moved thereabout.

One particular application exhibiting the deficiencies of existingbolsters involves the use of PEG tubes to provide long term access tothe stomach. A PEG tube is often maintained at its stoma site by aninternal and external retention bolster for several months while the PEGtube is used to provide access to the stomach. Existing bolsters,however, remain inflexibly clamped to the feeding tube so as to maintainthe catheter in position during use. As a consequence, these bolsters donot accommodate the unavoidable movements of the port during extendedperiods of time or, for example, the loss or gain of weight of thepatient subsequent to introduction of the port.

A need therefore exists for an improved retention bolster for useadjacent to a body surface to support a gastric port.

BRIEF SUMMARY

The foregoing problems are solved and technical advance is achieved withan illustrative gastric port system. The gastric port system fortransport of materials to the interior of a body cavity includes a portthat is configured to be disposed between a first body cavity and anarea adjacent to the first body cavity. The gastric port system includesa first bolster disposed on a first portion of the port and configuredto contact a bodily surface of the body cavity. The gastric port systemincludes a second bolster disposed on a second portion of the port andconfigured to contact a bodily surface of the area adjacent to thecavity. At least one of the first bolster and the second bolster isslidable relative to the port to allow relative movement between thebolsters. The first and second bolster each may include one or moremagnets that are configured so that the magnet on the first bolster isattracted to the magnet on the second bolster. Alternatively, one of thebolsters may be made of material that attracts a magnet.

The first bolster may also include a pocket configured to receive amagnet and the second bolster may include a pocket configured to receivea magnet. In another embodiment, one of the first bolster and the secondbolster may be a Malecot shaped bolster having a foldable member and apocket configured to receive a magnet.

In yet another embodiment, a medical device kit is disclosed. Themedical device kit may include a port, a catheter, a first bolster, asecond bolster, and at least one array of magnets to be disposed on thefirst bolster and the second bolster.

These and other advantages, as well as the gastric port system itself,will become apparent in the details of construction and operation asmore fully described below. Moreover, it should be appreciated thatseveral aspects of the invention can be used with other types of gastricport systems or medical devices.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is an illustration of a gastric port system;

FIG. 2 is an illustration of a retention bolster taken along line 2-2 ofFIG. 1;

FIG. 3 is an illustration of another embodiment of a gastric portsystem;

FIG. 4 is an illustration of a retention bolster taken along line 4-4 ofFIG. 3;

FIG. 5 is an illustration of a retention bolster for use in a gastricport system;

FIG. 6 is an illustration of a medical device kit that includes agastric port system.

DETAILED DESCRIPTION OF THE DRAWINGS AND THE PRESENTLY PREFERREDEMBODIMENTS

For the purposes of promoting an understanding of the principles of thegastric port system, reference will now be made to the embodimentsillustrated herein. It will nevertheless be understood that nolimitation of the scope of the invention is thereby intended, suchalterations and further modifications in the illustrated system, andsuch further applications of the principles of the invention asillustrated therein being contemplated as would normally occur to oneskilled in the art to which the invention relates.

Referring now to FIG. 1, a gastric port system 100 is shown transversinga stoma between a first body cavity 102 and an area 104 adjacent to thefirst body cavity 102. More specifically, and as illustrated in FIG. 1,the first body cavity 102 may be the abdominal cavity of a patient andarea 104 illustrated is an area external to the patient. However, thefirst body cavity 102 may be any body cavity that would benefit from theadvantages disclosed herein. Likewise, area 104 may be a second bodycavity adjacent to the first body cavity. For example, the first bodycavity 102 may be the abdominal cavity of the patient and the area 104may be the intestine of the patient.

Gastric port system 100 includes a port 106 that has a proximal portion108 and a distal portion 110. The proximal portion 108 may be defined asthe portion of the port 106 that extends into area 104 and the distalportion 110 may be defined as the portion of the port 106 that extendsinto first body cavity 102. The port 106 also includes a passageway 112that allows for the passage of materials through the port 106. Morespecifically, the passageway 112 allows for the passage of nutritionalproducts or medications directly into the body or body cavity of apatient. Alternatively, a catheter 114 may be introduced to extendthrough the passageway 112 and may act as the delivery mechanism formaterials directly into the body or body cavity of a patient. The port106 may be made of any material suitable for the placement of the port106 into a body or body cavity of a patient. Likewise, the catheter 114may be made of any material suitable for delivery of, for example,nutritional products or medications into the body or body cavity.

A first bolster 116 and a second bolster 118 are shown in FIG. 1. Thefirst bolster 116 may be disposed on the proximal portion 108 of theport 106 and the second bolster 118 may be disposed on the distalportion 110 of the port 106. The first bolster 116 may be slidablydisposed on the proximal portion 108 of the port 106. Alternatively, thefirst bolster 116 may be fixedly attached to the port 106. The firstbolster 116 and the second bolster 118 may be different sizes andshapes. For example, the bolsters 116 and 118 may be molded in one pieceout of medical grade resilient silicone and the like and may be ringshaped, bowl shaped, T-shaped, Malecot shaped, mushroom-shaped,dome-shaped, conical-shaped, or any other shape that can provideretention for the gastric port system.

The first bolster 116 may contain a magnet 120. The magnet 120 may be onthe surface of the bolster 116, such as a bar magnet or any other shapedmagnet. Alternatively, the magnet 120 may coat the entire surface areaof the bolster 116. The magnet 120 has a particular magnetic strength.As one skilled in the art will appreciate, the magnetic strength ofmagnet 120 may be chosen to provide a suitable magnetic strength neededfor a particular application, such as the varying thickness of anabdominal wall and the sensitivity of bodily tissue to trauma. Further,the bolster 116 may contain more than one magnet 120, variously arrangedon the surface of bolster 116. If there is more than one magnet 120, themagnets may have the same or different magnetic strengths, depending onthe particular application.

The second bolster 118 contains a magnet 122. The magnet 122 may be onthe surface of the bolster 118, or may be embedded within the bolster118. The magnet 122 may have a surface shape smaller than the surfacearea of the bolster 118, such as a bar magnet or any other shapedmagnet. Alternatively, the magnet 122 may coat the entire surface areaof the bolster 118. The magnet 122 has a particular magnetic strength.As one skilled in the art will appreciate, the magnetic strength ofmagnet 122 may be chosen to maximize the magnetic strength needed for aparticular application. Further, the bolster 118 may contain more thanone magnet 122, variously arranged on the surface of bolster 118. Ifthere is more than one magnet 122, the magnets may have the same ordifferent magnetic strengths, depending on the particular application,such as the varying thickness of an abdominal wall. The magnet 120 ofthe first bolster 116 is designed to be attracted to the magnet 122 ofthe second bolster. In an alternative embodiment, one of the bolsters116 and 118 may be made of material which is attracted to magneticmaterial, such as a metallic material.

FIG. 2, taken along line 2-2 in FIG. 1, illustrates the coaxialrelationship between the first bolster 116, the port 106, the passageway112, and the catheter 114. Additionally, FIG. 2 illustrates a lumen 200extending through the catheter 114 through which nutritional products,medication and the like may flow. While FIG. 2 shows a coaxialrelationship between the various components of the gastric port system100, it should be understood that a coaxial relationship between thecomponents is not necessary, and may be modified to suit a particularapplication as will be appreciated by one skilled in the art. FIG. 2shows magnet 120, as well as three additional magnets 202, 204, and 206respectively, disposed about the circumference of the bolster 116. Asone skilled in the art will appreciate, the port system 100 disclosedherein is not limited to a particular number of magnets. Indeed, more orless than four magnets may be used, and may be arranged on the surfaceof the bolster 116 in varying patterns, depending on the application.Moreover, while FIG. 2 illustrates the coaxial relationship of the firstbolster 116 with other components of the port system 100, it should beunderstood that bolster 118 may have the same or similar relationshiprelative to the port 106 and the catheter 114. Further, as is describedbelow, second bolster 118 may also have a magnet or magnets, arrangedsimilarly as those described above.

FIG. 1 illustrates the first bolster 116 engaging the first side 124 ofa bodily wall 126. The bodily wall 126 may be the material or spacebetween body cavity 102 and area 104. The second bolster 118 is alsoshown engaging a second side 128 of the bodily wall 126. As will beexplained in greater detail below, one or both the first bolster 116 andthe second bolster 118 may be slidable relative to the port 106 suchthat the distance between the first bolster 116 and the second bolster118 may be adjustable to compensate for or adjust to the thickness ofthe bodily wall 126.

In an embodiment where the first bolster 116 is slidable relative to theproximal portion 108 of the port 106, a first retaining mechanism 130may be included. The first retaining mechanism 130 may limit axialmovement of the first bolster 116 relative to the proximal portion 108of the port 106. In an embodiment where the second bolster 118 isslidable relative to the distal portion 110 of the port 106, a secondretaining mechanism 132 may be included. The second retaining mechanism132 may limit axial movement of the second bolster 118 relative to thedistal portion 110 of the port 106. The first retaining mechanism 130and the second retaining mechanism 132 may be a removable plastic twistlock, which is closed about the port 106 to apply a gripping pressure onthe port 106 and to prevent axial movement of the bolsters 116 and 118.The retaining mechanisms 130 and 132 may be removed or moved axiallyalong the port 106 to adjust the axial movement range of the bolsters116 and 118. Alternatively, the retaining mechanisms 130 and 132 may bebarbs (not shown) that protrude from the proximal portion 108 and thedistal portion 110 of port 106, respectively, and engage the bolsters116 and 118. The retaining mechanisms 130 and 132 prevent the port 106from being removed from the bolsters 116 and 118.

Referring now to FIG. 3 and FIG. 4 (taken along line 4-4 of FIG. 3), thegastric port system 100 is illustrated implementing the first bolster116 and a Malecot shaped second bolster 400. The bolster 116 is similarto that described above. The bolster 400 has a plurality of foldablemembers 402. In the embodiment illustrated, there is a magnet 404disposed on each respective foldable member. There may be additionalmagnets on each foldable member 402 or there may be no magnets on someof the foldable members 402. Further, with reference to FIGS. 2 and 4,the magnets 404 are configured to be attracted to magnets 120, 202, 204,and 206 respectively. The foldable members 402 provide retention for thebolster 400 and are well suited to provide retention support for thegastric port system 100. A particular advantage to bolster 400 that maystrengthen retention is that the bolster 400 may include additionalmagnets 406 which are designed to be attracted to magnets 404. In thisconfiguration, magnets 404 may be disposed on the proximal side offoldable members 402 and magnets 406 may be disposed on the distal sideof foldable members 402. The magnets 404 and 406 which are on opposingsides of each foldable member 402 will tend to retain the Malecotbolster 400 in the folded expanded configuration. Foldable members 402may be collapsed to allow insertion of the bolster 400 through thestoma, and expanded to secure the port 106.

FIG. 5 illustrates another embodiment of the gastric port system 100that may include a bolster 500 that may include pockets 502, 504, 506,and 508 that are configured to receive magnets (not shown). The pockets502, 504, 506, and 508 may be stitched onto the surface of the bolster500. Alternatively, the pockets 502, 504, 506, and 508 may be embeddedwithin the bolster 500. The pockets 502, 504, 506, and 508 may bedisposed on the bolster 500 such that magnets (not shown) may beinserted into one or more of the pockets 502, 504, 506, and 508.Depending on the application, each of the pockets 502, 504, 506, and 508may be configured to receive one or more magnets. While four pockets areshown, it should be understood that any number of pockets may bedisposed on bolster 500. For example, six pockets may be included andmagnets may be inserted into each pocket, or two magnets may be insertedinto three of the six pockets and so on. Further, the pockets 502, 504,506, and 508 may be configured so that they may engage and retainmagnets, such that the magnets are removable but will be retained withinthe pockets 502, 504, 506, and 508.

FIG. 6 illustrates a medical device kit 600 for use in the clinicalenvironment. The kit 600 may include the port 106, the catheter 114, thefirst bolster 116 and the second bolster 118. Preferably, the firstbolster 116 and the second bolster 118 include pockets 602, 604, 606,608, 610, 612, 614, and 616 which are configured to receive magnets. Thekit 600 may also include a first array 618 of magnets of varying sizesand magnetic strengths and a second array 620 of magnets of varyingsizes and magnetic strengths. Generally, the magnets in the first array618 are designed to be attracted to the magnets in the second array 620.However, certain magnets of the first array 618 may be attracted to eachother. Likewise, certain magnets of the second array 620 may beattracted to each other. The kit 600 may also include a wire guide 622and packaging 624.

It is therefore intended that the foregoing detailed description beregarded as illustrative rather than limiting, and that it be understoodthat it is the following claims, including all equivalents, that areintended to define the spirit and scope of this invention.

1-9. (canceled)
 10. A gastric port system for transport of materials tothe interior of a body cavity comprising: a port configured to bedisposed between a first body cavity and an area adjacent to the firstbody cavity; the port further comprising a distal portion, a proximalportion, and a passageway therethrough; a first bolster disposed on theproximal portion of the port, the first bolster including a firstmagnet; a second bolster disposed on the distal portion of the port, thesecond bolster including a second magnet; wherein at least one of thefirst bolster and the second bolster is slidable relative to the port;wherein the first magnet is attracted to the second magnet such that thefirst bolster and the second bolster are drawn together; and wherein thesecond bolster is a Malecot shaped bolster having at least one foldablemember where a magnet is disposed on the at least one foldable member.11-13. (canceled)
 14. A gastric port system for transport of materialsto the interior of a body cavity comprising: a port configured to bedisposed between a first body cavity and an area adjacent to the firstbody cavity; the port further comprising a distal portion, a proximalportion, and a passageway therethrough; a first bolster disposed on theproximal portion of the port, the first bolster including a first pocketconfigured to receive a first magnet; a second bolster disposed on thedistal portion of the port, the second bolster including a second pocketconfigured to receive a second magnet; and wherein at least one of thefirst bolster and the second bolster is slidable relative to the port.15. The gastric port system of claim 14 where the first bolster includesa plurality of first pockets configured to receive a plurality ofmagnets and the second bolster includes a plurality of second pocketsconfigured to receive a plurality of magnets.
 16. The gastric portsystem of claim 14 where the second bolster is a Malecot shaped bolsterhaving a foldable member, and where the second pocket configured toreceive a magnet is disposed on the foldable member.
 17. The gastricport system of claim 14 further comprising a catheter with a lumen forthe passage of materials extending through at least a portion of theport.
 18. The gastric port system of claim 14 where one of the firstbolster and the second bolster is fixedly attached to the port.
 19. Thegastric port system of claim 14 where the first bolster is slidablerelative to the proximal portion of the port and the second bolster isslidable relative to the distal portion of the port.
 20. The gastricport system of claim 19, where the port further comprises a firstretaining element for limiting axial movement of the first bolster and asecond retaining element for limiting axial movement of the secondbolster.
 21. The gastric port system of claim 14 where the port furthercomprises a retaining element for limiting axial movement of one of thefirst bolster and the second bolster.
 22. The gastric port system ofclaim 14 where the first body cavity is the abdominal cavity of thepatient.
 23. The gastric port system of claim 22 where the area adjacentto the first body cavity is external to the patient.
 24. The gastricport system of claim 14 where the first body cavity is the abdominalcavity of the patient and the area adjacent to the first body cavity isthe intestine of the patient.
 25. The gastric port system of claim 14further comprising a first magnet removably disposed in the first pocketand a second magnet removably disposed in the second pocket.
 26. Thegastric port system of claim 14 further comprising a plurality ofmagnets offering different magnetic properties configured to be disposedin the first pocket and the second pocket.
 27. A medical device kitcomprising: a port configured to be disposed between a first body cavityand an area adjacent to the first body cavity; the port furthercomprising a distal portion, a proximal portion, and a passagewaytherethrough; a first bolster disposed on the proximal portion of theport, the first bolster including a first pocket configured to receive afirst magnet; a second bolster disposed on the distal portion of theport, the second bolster including a second pocket configured to receivea second magnet; and an array of magnets.
 28. The medical device kit ofclaim 27 further comprising packaging material contained the medicaldevice kit.